Composition and method having enhanced LSESr to maintain and promote urinary and prostate function in a human

Abstract

A dietary supplement composition is formulated in a therapeutic amount to maintain and promote urinary and prostate function in a human. The composition includes a shelf stable, supercritical CO2 fluid extracted, enhanced lipidosterolic extract of Serenoa repens (LSESr). The enhanced LSESr has a ratio of free fatty acids to total fatty acids that is greater than about 80.0% and an enrichment of lauric, myristic, oleic and linoleic acids as free fatty acids to total free fatty acids that is greater than about 82.0%.

The invention claimed is: 
     
         1 . A dietary supplement composition formulated in a therapeutic amount to maintain and promote urinary and prostate function in a human, comprising:
 a shelf stable, supercritical CO 2  fluid extracted, enhanced lipidosterolic extract of  Serenoa repens  (LSESr), the enhanced LSESr having a ratio of non-esterified free fatty acids to total fatty acids that is about 80.0% to about 82.0% and an enrichment of lauric, myristic, oleic and linoleic acids as non-esterified free fatty acids to total non-esterified free fatty acids that is about 82.0% to about 86.0%.   
     
     
         2 . The dietary supplement composition of  claim 1  wherein the enhanced LSESr has a balance of about 90.0% of total fatty acids to about 72.0% of non-esterified free fatty acids. 
     
     
         3 . The dietary supplement composition of  claim 1  wherein the enhanced LSESr has a peroxide value that is less than about 3 meg/kg and a shelf stability of at least about 4 years without added antioxidants and stabilizers. 
     
     
         4 . The dietary supplement composition of  claim 1  wherein the dietary supplement composition is formulated into an oral dosage form. 
     
     
         5 . The dietary supplement composition of  claim 4  wherein the dietary supplement composition is formulated into an oral dosage form and in a capsule of about 160 b.i.d. to about 320 mg, or about minimum 200 mg per dose of enhanced LSESr. 
     
     
         6 . The dietary supplement composition of  claim 1  wherein the dietary supplement composition includes less than about 0.2 percent w/w of saw palmetto sterols. 
     
     
         7 . The dietary supplement composition of  claim 1  wherein the dietary supplement composition includes a dry excipient comprising at least one of silicon dioxide, calcium silicate, calcium phosphate, magnesium oxide, magnesium carbonate, calcium carbonate, rice fiber, and maltodextrin. 
     
     
         8 . A dietary supplement composition formulated in a therapeutic amount in an oral dosage form and in a single dosage capsule to maintain and promote urinary and prostate function in a human, comprising:
 a shelf stable, supercritical CO 2  fluid extracted, enhanced lipidosterolic extract of  Serenoa repens  (LSESr), the enhanced LSESr having a peroxide value of less than 3 meg/kg and a shelf stability of at least about 4 years without added antioxidants and stabilizers, the enhanced LSESr comprising,   an enrichment of lauric, myristic, oleic and linoleic non-esterified free fatty acids to total non-esterified free fatty acids of about 82.0% to about 86.0%; and   a ratio of non-esterified free fatty acids to total fatty acids of about 80.0% to about 82.0%.   
     
     
         9 . The dietary supplement composition of  claim 8  wherein the dietary supplement composition is formulated into an oral dosage form and in a capsule of about 160 mg b.i.d. to about 320 mg, or about minimum 200 mg per dose of enhanced LSESr. 
     
     
         10 . The dietary supplement composition of  claim 8  wherein the dietary supplement composition includes less than about 0.2 percent w/w of saw palmetto sterols. 
     
     
         11 . The dietary supplement composition of  claim 8  wherein the dietary supplement composition includes a dry excipient comprising at least one of silicon dioxide, calcium silicate, calcium phosphate, magnesium oxide, magnesium carbonate, calcium carbonate, rice fiber, and maltodextrin. 
     
     
         12 . The dietary supplement composition of  claim 8  wherein the enhanced LSESr comprises from about 90.0% of total fatty acids to about 72.0% of non-esterified free fatty acids. 
     
     
         13 . A method to maintain and promote urinary and prostate function in a human by administering a therapeutic amount of a dietary supplement composition to the human in need thereof comprising:
 a shelf stable, supercritical CO 2  fluid extracted, enhanced lipidosterolic extract of  Serenoa repens  (LSESr), the enhanced LSESr having a ratio of non-esterified free fatty acids to total fatty acids that is about 80.0% to about 82.0% and an enrichment of lauric, myristic, oleic and linoleic acids as non-esterified free fatty acids to total non-esterified free fatty acids that is about 82.0% to about 86.0%.   
     
     
         14 . The method of  claim 1  wherein the enhanced LSESr has a balance of about 90.0% of total fatty acids to about 72.0% of non-esterified free fatty acids. 
     
     
         15 . The method of  claim 13  wherein the enhanced LSESr has a peroxide value that is less than about 3 meg/kg and a shelf stability of at least about 4 years without added antioxidants and stabilizers. 
     
     
         16 . The method of  claim 13  wherein the dietary supplement composition is formulated into an oral dosage form. 
     
     
         17 . The method of  claim 16  wherein the dietary supplement composition is formulated into an oral dosage form and in a capsule of about 160 mg b.i.d. to about 320 mg, or about minimum 200 mg per dose of enhanced LSESr. 
     
     
         18 . The method of  claim 13  wherein the dietary supplement composition includes less than about 0.2 percent w/w of saw palmetto sterols. 
     
     
         19 . The method of  claim 13  wherein the dietary supplement composition includes a dry excipient comprising at least one of silicon dioxide, calcium silicate, calcium phosphate, magnesium oxide, magnesium carbonate, calcium carbonate, rice fiber, and maltodextrin.